MiMedx completed enrollment for a Phase III study of plantar fasciitis. This clinical trial is exploring ways that placental science may address and treat musculoskeletal pain and function disorders. It is designed to provide statistically significant evidence of efficacy for such a biologic treatment to reduce pain and improve function.
The current treatment algorithm aims to maintain arch shape, modify foot loading and/or improve shock absorbency of the heel through night splints and orthotics. While they may assist in reducing pain associated with plantar fasciitis, these treatments do not address the root cause of the condition, which is thought to be degenerative and inflammatory.
This Phase III, prospective, double-blinded, randomized controlled trial will compare micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection vs. saline placebo injection. The trial enrolled 276 patients.
Timothy R. Wright, MiMedx Chief Executive Officer, said, “Given the variability of efficacy, cost, and potential side effects of available plantar fasciitis treatment options, additional evidence-based alternatives are needed urgently...Using our placental science platform to address the unmet need posed by plantar fasciitis is just one of the critical ways that we are exploring its application to improve people’s lives. We look forward to sharing the results of this trial in 2021.”